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Public consultation and major updates from French Data Protection Authority on health data and research

On May 16, 2024, the CNIL announced a critical public consultation and three significant updates to adapt health research regulations in France. These updates, focusing on remote quality...

Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU

The Q1/24 Life Science and Health Care Law Update covers key trends across EU life sciences regulatory, corporate, compliance, competition, and privacy.Key new developments: Pharma: EC ...

News

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...

Insights and Analysis

Hogan Lovells 2024 M&A Outlook

Our 10th annual M&A Year in Review features a 2024 M&A Outlook, which provides insights across the key topics that we expect will influence dealmaking in the months to come:...

News

UK MHRA Publishes AI Regulatory Strategy

On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI ...

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The use of IVDs as CDx in pharmaceutical clinical trials

The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for...

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Center for Clinical Trial Innovation furthers FDA’s diversity goals, rare disease drug development

The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is...

News

2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

News

FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework

The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...

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